Panels › Immunology › Product code DHN · Class 2
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation 866.5100
0510(k)s in 12 months (110 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in DHN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 1978 | K780178 | TEST SYS. FOR NDNA ANTIBODY DETERM. Zeus Scientific, Inc. | DHN |
| Feb 7, 1978 | K780161 | IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER Zeus Scientific, Inc. | DHN |
| Jan 20, 1978 | K772219 | FIAX TEST FOR ANTI-RUBELLA ANTIBODY Idt, A Division of Whittaker M.A. Bioproducts | DHN |
| Oct 18, 1977 | K771376 | IFA ANTI-NDNA Electro-Nucleonics Laboratories, Inc. | DHN |
| Jun 24, 1977 | K771064 | ANA TEST Gull Laboratories, Inc. | DHN |
| Apr 5, 1977 | K770057 | NDNA IMMUNOPATH FLUORO-KIT Clinical Sciences, Inc. | DHN |
| Oct 21, 1976 | K760681 | INDIRECT FLUORESCENT (IFA-ANA) Wampole Laboratories | DHN |
| Aug 3, 1976 | K760206 | TEST, DETECTION, ANTINUCLEAR ANTIBODIES Intl. Diagnostic Technology | DHN |
| Jul 26, 1976 | K760209 | ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP Zeus Scientific, Inc. | DHN |
| Jul 20, 1976 | K760153 | TEST, (IVDP) ANTINUCLEAR ANTIBODY Zeus Scientific, Inc. | DHN |
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